MAUDE Adverse Event Report: BIOTRONIK BIVENTRICULAR SYSTEM; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 0180

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pocket Erosion (2013)

Event Type  Injury  

Event Description

Patient was following up for her device coming through her skin.Antibiotics were prescribed.Erosion progressed.Extraction of bi-v system performed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BIVENTRICULAR SYSTEM
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17489422
• MDR Text Key: 320691728
• Report Number: MW5121967
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 0180
• Patient Sequence Number: 1